pSivida Announces an Evaluation Agreement with Hospital for Special Surgery To Investigate Bioerodible Sustained Release Systems in Orthopedic Surgery
WATERTOWN, Mass. & NEW YORK, Aug 16, 2011 (BUSINESS WIRE) -- Drug delivery company pSivida Corp. /quotes/zigman/111048/quotes/nls/psdv PSDV +3.99% (asx:PVA) today announced it has entered into an evaluation agreement with Hospital for Special Surgery (HSS), a world leader in orthopedics, rheumatology and rehabilitation, to investigate pSivida's drug delivery technologies in orthopedics.
This agreement follows pSivida's announcement in June that it has renegotiated its collaboration agreement with Pfizer to focus solely on developing a bioerodible sustained release implant for glaucoma and ocular hypertension. (This program is already in clinical trials).
"We believe this orthopedic evaluation agreement is important for pSivida as our drug delivery technology, originally developed for ophthalmology, is being investigated in broader areas of medicine," said Dr Paul Ashton, President and CEO of pSivida. "We are excited to be working with Hospital for Special Surgery because of their long history of innovation and research in orthopaedic surgery."
About Hospital for Special Surgery
Founded in 1863, Hospital for Special Surgery (HSS) is a world leader in orthopedics, rheumatology and rehabilitation. HSS is nationally ranked No. 1 in orthopedics, No. 2 in rheumatology, No. 19 in neurology and No. 16 in geriatrics by U.S. News & World Report (2011-12), has received Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center, and has one of the lowest infection rates in the country. From 2007 to 2011, HSS has been a recipient of the HealthGrades Joint Replacement Excellence Award. HSS is a member of the NewYork-Presbyterian Healthcare System and an affiliate of Weill Cornell Medical College, and as such all Hospital for Special Surgery medical staff are on the faculty of Weill Cornell. The hospital's research division is internationally recognized as a leader in the investigation of musculoskeletal and autoimmune diseases. Hospital for Special Surgery is located in New York City and online at www.hss.edu .
About pSivida Corp.
pSivida is a world leader in the development of tiny drug delivery products that are administered by implantation, injection or insertion and provide sustained release of drugs on a controlled and level basis for months or years. The Company uses these systems to develop treatments for serious, unmet, medical needs. The Company's most advanced product candidate, ILUVIEN(R), delivers fluocinolone acetonide (FA) for the treatment of diabetic macular edema (DME). DME is a leading cause of vision loss, affecting more than a million people in the US alone, for which there is currently no FDA-approved drug therapy. ILUVIEN is licensed to Alimera Sciences, Inc., which has completed Phase III clinical trials and submitted a New Drug Application (NDA) with the Food and Drug Administration (FDA) in June 2010 based on 24-month data. In August 2010, the FDA granted Priority Review status for the NDA, and in December 2010, the FDA issued a Complete Response Letter (CRL). In February 2011, Alimera reported 36-month top-line results from the completed Phase III clinical trials and in May 2011, Alimera reported data which analyzed the subgroup of patients who had been diagnosed with DME for three or more years at entry of the study. Alimera resubmitted the NDA for ILUVIEN to the FDA on May 12, 2011 to address questions raised in the CRL and reported that data from the subgroup of patients with chronic DME was also provided together with additional information regarding controls and specifications on the manufacturing, packaging and sterlization of ILUVIEN. pSivida has two products approved by the FDA for sustained release delivery of drug to treat chronic back-of-the-eye diseases: Retisert(R) for the treatment of posterior uveitis and Vitrasert(R) for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. pSivida has licensed both of these products and the technologies underlying them to Bausch & Lomb Incorporated. pSivida's intellectual property portfolio consists of over 50 patent families, more than 100 granted patents, including patents accepted for issuance, and more than 150 patent applications. pSivida conducts its operations from Boston in the United States and Malvern in the United Kingdom.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: ability of pSivida, with HSS, another partner or alone, to successfully develop, obtain regulatory approval for, finance, and commercialize an orthopedic implant ability of pSivida, with Pfizer, another partner or alone, to successfully develop, obtain regulatory approval for, finance, and commercialize a latanoprost implant; ability to obtain additional capital uncertain; future losses; impairment of intangibles; fluctuations in the fair values of certain outstanding warrants; fluctuations in operating results; decline of royalty income from Bausch & Lomb; Alimera's ability to obtain regulatory approval of ILUVIEN; Alimera's ability to successfully commercialize ILUVIEN if approved; risk/benefit profile of ILUVIEN; timeliness of approval, if any, of ILUVIEN and any limitations on uses thereof; ability to complete clinical trials and obtain regulatory approval of other product candidates; ability to find partners to develop and market products; termination of license agreements; competition; market acceptance of products and product candidates; reduction in use of products as a result of future publications; ability to protect intellectual property or infringement of others' intellectual property; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution through exercise of outstanding warrants and stock options or future stock issuances; possible influence by Pfizer; ability to pay any registration penalties; absence of dividends; and other factors described in our filings with the Securities and Exchange Commission. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.